Coloplast Manufacturing US, LLC: Medical Device Recall in 2021 - (Recall #: Z-0413-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Torosa Saline-Filled Testicular Prosthesis (Size Small)

Product Classification:

Class II

Date Initiated: November 9, 2021

Date Posted: December 29, 2021

Recall Number: Z-0413-2022

Event ID: 89029

Reason for Recall:

Product is mislabeled for size.

Status: Terminated

Product Quantity: 19 units

Code Information:

SKU# 5206102400; Catalo # (450-1325); Lot 7685283

Distribution Pattern:

Worldwide distribution - US Nationwide distribution and the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated